ArticleCytotherapy2026
A phase 1b study on the safety of Wharton's jelly mesenchymal stromal cells in the treatment of acute graft-versus-host disease.
Article in Cytotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03158896 (A Phase I Study To Evaluate the Safety of Umbilical Cord - Derived, Ex-Vivo Cultured and Expanded Wharton's Jelly Mesenchymal Stem Cells for the Treatment of De Novo High Risk Acute or Steroid Refractory Acute Graft Versus Host Disease), which is not on this map. Not yet cited in PubMed.
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A Phase I Study To Evaluate the Safety of Umbilical Cord - Derived, Ex-Vivo Cultured and Expanded Wharton's Jelly Mesenchymal Stem Cells for the Treatment of De Novo High Risk Acute or Steroid Refractory Acute Graft Versus Host Disease
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10 authors.
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Abstract
BACKGROUND
aimsSteroid-refractory (SR) and high-risk (HR) acute graft-versus-host disease (aGVHD) is a major complication of allogeneic hematopoietic stem cell transplantation. Mesenchymal stromal cells (MSCs) possess immunomodulatory potential, and Wharton's jelly MSCs, a rapidly expanding subset of cells that exhibit potent in vitro suppression of T-cell proliferation, may benefit patients in the setting of SR/HR aGVHD. The objective of this study was to evaluate the safety and preliminary efficacy signals of multiple-dose MSCTC-0010, an umbilical cord-derived Wharton's jelly MSC product, in patients with SR or HR aGVHD.
methodsThis was a prospective, single-center, open-label phase 1b trial (NCT03158896). Adults (18-76 years old) with de novo HR or SR aGVHD unresponsive to ≥1.6 mg kg⁻¹ day⁻¹ methylprednisolone were enrolled. Three sequential cohorts received 2 × 10
resultsTwenty-four patients received an infusion; median age was 59 years and 66% were male. No TRAEs were observed. One patient experienced transient infusion-related dyspnea. No ectopic tissue formation was detected on CT imaging at day 90. By day 28, 71% of patients demonstrated clinical improvement: 33% achieved CR and 38% achieved a partial response (PR). By day 90, 54% of patients showed improvement (CR 42%, PR 13%). Median time to additional systemic therapy (ruxolitinib ± extracorporeal photopheresis) was 15 days; 75% ultimately required escalation. Median overall survival was 7.0 months for all patients and 30 months for those completing all planned doses.
conclusionsMSCTC-0010 demonstrated an excellent safety profile with no grade ≥3 TRAEs and no ectopic tissue formation. Promising early efficacy-including 71% day 28 OR and 42% day 90 CR in a population with historically poor outcomes-supports further investigation. A randomized multicenter phase 2 trial combining or sequencing MSCTC-0010 with ruxolitinib is warranted to clarify its therapeutic contribution in HR/SR aGVHD.
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